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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph Software For Over-The-Counter Use
510(k) Number K243236
Device Name WHOOP ECG (electrocardiogram) Feature (1.0)
Applicant
Whoop., Inc.
One Kenmore Sq
Boston,  MA  02215
Applicant Contact Nikki Batista
Correspondent
Whoop., Inc.
One Kenmore Sq
Boston,  MA  02215
Correspondent Contact Shweta Parwe
Regulation Number870.2345
Classification Product Code
QDA  
Date Received10/10/2024
Decision Date 04/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT06622265
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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